Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Goserelin | Zoladex | 4.8 Undesirable effects | Convulsions , suicidal ideation and attempt in women | Mar,2023 |
| Fluticasone Furoate,Umeclidinium Bromide,Vilanterol | Trelegy Ellipta | 4.8 Undesirable effects | Dysuria, urinary retention | Mar,2023 |
| Chadox1-S | R-Covi | 4.8 Undesirable effects | Cutaneous vasculitis | Mar,2023 |
| Amikacin | Miacin | 4.4 Special Warnings and Special Precautions for Use | Updated Neuro/Ototoxicity section to include genetic mutations | Mar,2023 |
| Cabazitaxel | Jevtana | 4.8 Undesirable effects | Nail disorder, gastrointestinal haemorrhage, ileus, gastritis, colitis, and gastrointestinal perforation | Mar,2023 |
| Onasemnogene Abeparvovec | Zolgensma | 4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects | Addition of baseline laboratory testing/ Hepatotoxicity , Transient decrease in platelet count to levels, liver failure with fatal outcome | Mar,2023 |